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Effectiveness of Robot-Assisted Structured Foot-Ankle Sensorimotor Training in Stroke Patients

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Aug 1, 2026 to Feb 15, 2027 · Start date changed from estimate of Aug 1, 2025 to Mar 1, 2026 · Primary endpoints: 12 to 1 · 7 morev2 Show 10 more changesShow less
    • Primary completion date: Aug 1, 2026 to Feb 15, 2027
    • Start date changed from estimate of Aug 1, 2025 to Mar 1, 2026
    • Primary endpoints: 12 to 1
    • Completion date: Dec 1, 2026 to May 15, 2027
    • Eligibility criteria expanded, about 101 words
    • Secondary endpoints expanded, about 78 words
    • Study description shortened, about 103 words
    • Study sites revised (2)
    • Collaborators expanded, about 8 words
    • Publications: details revised at 7 of 40 entries

    See this version in full on ClinicalTrials.gov ↗

  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Medipol University
152 trials monitored
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Stroke
3,289 trials monitored
See 141 trials at risk
Introduction: Stroke is a leading cause of long-term disability worldwide. Persistent lower-extremity motor and somatosensory impairments after stroke commonly limit walking and balance despite rehabilitation. Virtual reality (VR)-integrated robotic rehabilitation may support structured, goal-directed ankle-foot practice; however, there is limited evidence for ankle-foot-focused sensorimotor protocols. In particular, approaches that combine robot-assisted motor training with a plantar tactile localization task and VR-supported joint position sense (JPS) training to target plantar sensory and proprioceptive function are scarce. Therefore, this study aims to evaluate the effectiveness of a structured, VR-integrated, robot-assisted ankle-foot sensorimotor rehabilitation protocol in individuals with chronic stroke and to examine its effects on clinical and sensorimotor outcomes. Methods and analysis: This is an assessor-blinded, two-arm, parallel-group randomized controlled trial. Thirty individuals with chronic stroke will be randomized 1:1 to the Robot-assisted Training Group (RTG) or the Manual Training Group (MTG). All participants will receive conventional rehabilitation; in addition, RTG will receive a structured robot-assisted ankle-foot training program integrated with virtual reality and assist-as-needed control, whereas MTG will receive the same structured ankle-foot training protocol delivered manually by a physiotherapist. Interventions will be delivered three times per week for 6 weeks (18 sessions), and total session duration will be time-matched between groups (50-60 min per session). The primary outcome will be the change in walking speed, derived from the 10-Meter Walk Test, from baseline to 6 weeks. Secondary outcomes will include 2-Minute Walk Test distance, ankle range of motion, joint position sense, plantar tactile sensation, muscle tone, motor performance, static and dynamic balance, and stroke-specific quality of life.
Trial Details
NCT Number NCT07091045
Lead Sponsor Medipol University
Collaborators: The Scientific and Technological Research Council of Turkey
Conditions Stroke
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov